LEARN-6™: A Prospective, Observational Nursing Home Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00727571
First received: July 31, 2008
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

This is a prospective, multicenter, observational, hypothesis-generating study exploring mobility, Quality of Life and other physical performance measures among older, long-term stay Nursing Home residents with CKD, with versus without anemia. Enrolled patients will participate in the study up to a total of 26 weeks and be assessed at Weeks 1, 2, 14 and 26/End of Study. Based upon Week 1 hemoglobin and serum creatinine lab results, participants will be categorized into 1 of 4 groups.


Condition Intervention
Anemia
Chronic Kidney Disease
Other: Observations

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Observational Study to Evaluate Physical Performance and Quality of Life in Older Long Stay Nursing Home Residents With Chronic Kidney Disease With and Without Anemia

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
    The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).


Secondary Outcome Measures:
  • Number of Participants With Anemia [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.

  • Percentage of Participants With Anemia Related Conditions at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative.

    Vitamin B12 and folate deficiency based on standard laboratory ranges.


  • Estimated Glomerular Filtration Rate (GFR) for Participants With CKD [ Time Frame: Weeks 1, 14 and 26 ] [ Designated as safety issue: No ]
    Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x [Serum creatinine]^-1.154 x [Age]^-0.203 x [0.742 if patient is female] x [1.210 if patient is black]. 2. Cockcroft-Gault formula: GFR = (140-age) * (Weight in kg) * (0.85 if female) / (72 * Serum Creatinine).

  • Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
    Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.

  • Physical Performance: Duration Walked or Wheeled at Each Visit [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.

  • Physical Performance: Time to Rise From Sitting to Standing [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.

  • Physical Performance: Grip Strength [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.

  • Physical Performance: Lower Extremity Strength, Left Leg. [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.

  • Physical Performance: Lower Extremity Strength, Right Leg [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.


Biospecimen Retention:   None Retained

N/A (None Retained)


Enrollment: 815
Study Start Date: September 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No CKD or Anemia
Chronic kidney disease (CKD) is based on estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
No CKD, but Anemia
CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
CKD with Anemia
CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
CKD with no Anemia
CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used

Detailed Description:

Study Design: Multicenter, non-interventional, 26-week, prospective, observational study of older, long-term stay residents with CKD, with and without anemia, in US Nursing Homes.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Older, long-term stay Nursing Home (NH) residents with CKD, with and without anemia

Criteria

Inclusion Criteria:

  • Age > 65 years
  • Long-term resident of NH as documented in medical record by Director of Nursing (DON) or Medical Director or as indicated in Minimum Data Set (MDS) Section Q
  • Able to walk at least 1 step or propel wheelchair 1 revolution of wheel
  • Able to follow a one-step instruction
  • Written informed consent

Exclusion Criteria:

  • Admitted to NH for short stay rehabilitation (anticipated stay less than 3 months)
  • Receiving Renal Replacement Therapy (RRT)
  • Major surgery within the past 3 months
  • Life expectancy < 6 months or receiving palliative care
  • Currently enrolled in or has not yet completed at least 30 days since ending investigational device or drug study(s), or is receiving investigational agent(s)
  • Currently is enrolled in an interventional trial
  • Previously withdrawn from this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727571

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00727571     History of Changes
Other Study ID Numbers: 20050239
Study First Received: July 31, 2008
Results First Received: October 29, 2009
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board
United States: Quorom Institutional Review Board

Keywords provided by Amgen:
Anemia
Chronic Kidney Disease
Quality of Life
CKD
Chronic Renal Insufficiency

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 31, 2014